MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. LIGATING DEVICE

Model Number	HX-20U-1
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Cut (2587); Ejection Problem (4009)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	01/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hx-20u-1 ligating device has not been returned to the service center for evaluation for "not releasing and getting stuck in a polyp".Therefore, the exact cause of the reported event cannot be determined.Upon return of the device, an evaluation will be performed, and a supplemental report will be submitted.
Event or Problem Description
The service center received a report of a ligating device, reusable loop, (hx-20u-1), lot number 98k, that would not release from a polyp and had to be surgically retrieved.The physician was performing a polypectomy and used two loops to cut a polyp when one loop became stuck in a large polyp.It was reported the loop device would not release from the accessory, and the physician had to perform surgery to retrieve the polyp with the loop.It was not reported the length of time the patient was under general anesthesia but it was reported there was no blood loss.It was reported the surgery was successful and the patient was stable.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the original equipment manufacturer (oem).Please see updated sections: d10, g4, g7, h2, h3, h6 and h10.The device was not returned to the service center for evaluation, therefore we are unable to provide the root cause of the reported event.The original equipment manufacturer (oem) performed a device history record (dhr) review for the finished product and no deviations or non-conformances were noted in the documentation or the processes.

• Brand Name: LIGATING DEVICE
• Common Device Name: LIGATING DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9742916
• Report Number: 8010047-2020-01479
• Device Sequence Number: 2533550
• Product Code: FHN
• UDI-Device Identifier: 04953170044922
• UDI-Public: 04953170044922
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: CLASS2-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HX-20U-1
• Device Lot Number: 98K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 02/23/2020
• Supplement Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1